Blood Lipid Test Strip

GUDID 06935740726986

Urit Medical Electronic Co., Ltd.

Multiple clinical chemistry analyte monitoring system IVD, home-use
Primary Device ID06935740726986
NIH Device Record Keyded875ff-63e4-416b-91b2-59fc0ae550fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Lipid Test Strip
Version Model NumberPFS 30,10strips/vial×2/box
Company DUNS653742429
Company NameUrit Medical Electronic Co., Ltd.
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106935740726986 [Primary]
GS186935740726982 [Unit of Use]

FDA Product Code

CHHEnzymatic Esterase--Oxidase, Cholesterol

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-22
Device Publish Date2024-07-12

Devices Manufactured by Urit Medical Electronic Co., Ltd.

06935740726993 - Hemoglobin Test Strip2024-09-30
06935740726986 - Blood Lipid Test Strip2024-07-22
06935740726986 - Blood Lipid Test Strip2024-07-22
06935740727006 - Uric Acid Test Strip2024-07-22
06935740727013 - Uric Acid Test Strip2024-07-22
06935740727020 - Uric Acid Test Strip2024-07-22
06935740727037 - Uric Acid Test Strip2024-07-22
06935740733830 - Hemoglobin Test Strip2024-07-22
06935740733847 - Hemoglobin Test Strip2024-07-22

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